Protocol/serial number

Study information

Scientific title

Acronym

HC-SAP

Study hypothesis

Supraphysiologic doses of hydrocortisone may result in earlier reversal of shock and thus lead to faster recovery from multiple organ dysfunction syndrome and better survival in patients with severe acute pancreatitis and shock.

Ethics approval

1. Ethics Committee of the Department of Surgery in the Hospital District of Helsinki and Uusimaa has approved study protocol on the 8th September 2008 (ref: 193/13/03/02/08) 2. National Agency for Medicines has approved study protocol on the 4th October 2008 (KLnro: 108/2008)

Study design

Multicentre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute pancreatitis

Intervention

Continuous intravenous infusion of hydrocortisone 300 mg/24 hours for 5 days, then 150 mg/24 hours for 3 days and then 50 mg/24 hours for 4 days. Placebo group receives infusion of comparable volume of physiologic saline for 12 days. Venous blood samples are collected before start of intervention and on days 1, 2, 3, 4, 5, 7, 14, 21 and 28 after randomisation.

Intervention type

Drug

Phase

Not Specified

Drug names

Hydrocortisone

Primary outcome measures

Intensive Care Unit (ICU) free days within first 60 days after randomisation.

Secondary outcome measures

1. Survival without vasopressor support within 60 days after randomisation2. Requirement of vasopressor treatment (area under curve [AUC] of norepinephrine dose) for 5 days after randomisation3. Organ failure free time (days with Sepsis-related Organ Failure Assessment [SOFA]-score less than 5) within 60 days after randomisation4. Ventilator free days within 60 days after randomisation5. Days free from renal replacement therapy within 60 days after randomisation6. Mortality at day 28 and day 90 after admission to hospital7. Changes of inflammatory mediators, markers of coagulation and serum free cortisol during ICU stay8. Incidence of infected pancreatic necrosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Lack of written informed consent from patient or next of kin2. Time from admission to hospital over seven days3. Vasopressor support continued without interruption over 48 hours4. Aged less than 18 years or greater than 65 years 5. Pregnancy or breastfeeding6. More than two previous attacks of acute pancreatitis7. Chronic pancreatitis or presence of complication after previous acute pancreatitis like pseudocyst8. Hepatitis B, hepatitis C or human immunodeficiency (HIV) infection9. Presence of acute infection (urinary, pulmonary, skin or soft-tissue infection)10. Major abdominal, thoracic or vascular surgery within last 30 days11. Severe chronic liver disease12. Severe heart failure